Manager / TL Aseptic Manufacturing 1100am-730pm

Pfizer•Rochester, MI

20h•Onsite

About The Position

The successful candidate will oversee a team of manufacturing operators engaged in the production of aseptic pharmaceutical products. This role requires strong personal leadership, initiative, sound judgment, accountability, and exceptional planning and organizational capabilities. The manager will exhibit strong communication skills, integrity, and the ability to collaborate effectively with diverse colleagues and groups. Responsibilities include managing production cost centers, supervising manufacturing personnel to ensure high-quality output, and upholding rigorous regulatory compliance standards. The position contributes to the development of both behavioral and technical competencies within a culture of continuous improvement to support patient needs. This role specifically involves overseeing aseptic prep, micronizing, gel compounding, formulation, and filling of sterile injectable products at the Rochester site. Collaboration with a team of managers and technical staff is essential for operational excellence. The manager will possess strong teamwork and advanced technical skills, including the ability to troubleshoot and resolve issues related to existing processes and equipment. Comprehensive knowledge of compliance requirements, as well as pharmaceutical, pharmacological, biological, biochemical, medical, and microbiological principles, is expected. As a manager, you will be accountable for achieving objectives, preparing resource forecasts, providing technical guidance and oversight, assisting with problem-solving, and supporting the professional development of colleagues, including effective counseling and corrective action.

Requirements

Bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Previous supervisory or related experience.
Strong personal motivation and aptitude for coaching, leading, and managing individuals and teams.
Aptitude for understanding process technology and equipment.
Aseptic processing knowledge.
Proven leadership ability.
Decision making ability.
Excellent oral and written communication skills.
Demonstrated ability to interact effectively with all levels of the organization.
Flexibility to respond to constantly changing conditions and priorities.
Comprehensive knowledge of compliance requirements, as well as pharmaceutical, pharmacological, biological, biochemical, medical, and microbiological principles.
Must not be allergic to penicillin (due to working in a Penicillin facility).
Permanent work authorization in the United States.

Nice To Haves

Relevant pharmaceutical industry experience.
Previous leadership experience.
Experience in providing technical leadership while working remotely.
Strong project management skills.
Ability to navigate complex organizational structures.
Experience in fostering both behavioral and technical growth within an organization.
Strong collaboration skills.
Experience in setting objectives and forecasting resource needs.
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

Oversee a team of manufacturing operators engaged in the production of aseptic pharmaceutical products.
Manage production cost centers.
Supervise manufacturing personnel to ensure high-quality output.
Uphold rigorous regulatory compliance standards.
Contribute to the development of both behavioral and technical competencies within a culture of continuous improvement to support patient needs.
Oversee aseptic prep, micronizing, gel compounding, formulation, and filling of sterile injectable products at the Rochester site.
Collaborate within a team of managers and technical staff to ensure operational excellence.
Troubleshoot and resolve issues related to existing processes and equipment.
Achieve objectives and prepare resource forecasts.
Provide technical guidance and oversight to your team.
Assist with problem-solving.
Support the professional development of colleagues.
Ensure effective counseling and corrective action when necessary.
Manage staff engaged in production or process completion, ensuring full compliance with regulatory requirements, cGMPs, GDPs, and company policies, procedures, and objectives.
Coordinate multiple departmental projects, often involving collaboration with cross-functional teams.
Devise solutions for a variety of complex challenges that demand regular use of creativity, innovation, and ingenuity.
Work collaboratively with quality, production, procurement, suppliers, and forwarding agents to maintain consistent supply.
Liaise with senior personnel both within and outside the company on issues that often require organizational coordination.
Support investigations and continuous improvement efforts by applying tools to enhance quality, reduce costs, improve safety, or shorten cycle times.
Maintain audit readiness and organize daily production activity schedules.
Lead, mentor, and develop team members to encourage ongoing growth and establish attainable goals.
Deliver product quality and production results punctually and within budget.
Promote high performance through effective management and development of a versatile workforce.
Design efficient workflows, monitor specific outcomes, and address areas for process improvement.
Act as a subject matter expert for the team when needed and provide support regarding equipment or human error deviations.
Advocate for best practices in aseptic techniques and behaviors by offering timely feedback.
Assist with the creation of On-the-Job Training (OJT) documentation.
Complete necessary SAP transactions for processes.
Review batch records before and after processing to ensure accuracy and completion.
Oversee Tier 2 Digital Operations Center (DOC), including the daily schedule, shift meeting board assignments, daily priorities, and operator rotation planning.
Initiate EAMS Maintenance work orders.
Distribute new and updated Standard Operating Procedures (SOPs) and forms.
Complete checklists for material order processing.
Review LUMACs and logbooks for accuracy and compliance.
Maintain personal operator qualifications to ensure effective support across all manufacturing operations.
Conduct timecard reviews and approvals.
Supervise performance of Manufacturing and Aseptic Technicians teams.
Prepare Manufacturing Event Reports as required.

Benefits

Comprehensive and generous benefits and programs.
401(k) plan with Pfizer Matching Contributions.
Additional Pfizer Retirement Savings Contribution.
Paid vacation.
Holiday and personal days.
Paid caregiver/parental leave.
Paid medical leave.
Health benefits to include medical, prescription drug, dental and vision coverage.
Annual base salary for this position ranges from $106,000.00 to $176,600.00.
Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary.
Eligibility to participate in our share based long term incentive program.
Relocation support available (based on business needs and/or eligibility).